FDA Inspection 893818 — Excelsior Medical LLC
The FDA completed an inspection of Excelsior Medical LLC on August 21, 2014 in Neptune, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Neptune, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3159 | 21 CFR 820.184 | DHR content |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |